The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study

November 21, 2011 updated by: Anders Kvanta

A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)

Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. For this reason, anti-VEGF drugs, in particular ranibizumab, as become the treatment of choice for neovascular AMD. Ranibizumab use is limited by its high cost. Also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. Strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. Combination therapy is an attractive such possibility. Transpupillary thermotherapy (TTT) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. Several reports have indicated that TTT may be used to slow disease progression in patients with neovascular AMD. In this study we examine whether combined ranibizumab and TTT will reduce the number of ranibizumab injections compared with ranibizumab alone (sham TTT). The study will go on for 2 years with an interim report after 1 year.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11282
        • St Eriks Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with subfoveal neovascular AMD with either classic/predominantly classic or occult lesions
  • visual acuity => 20/200

Exclusion Criteria:

  • subretinal fibrosis or atrophy under the fovea
  • patients previously treated for neovascular AMD in the study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TTT
TTT is given every three months
Biological: ranibizumab
0.5 mg intravitreal injection
Other Names:
  • Lucentis
Procedure: TTT
Transpupillary thermotherapy (TTT)
SHAM_COMPARATOR: Sham TTT
Sham TTT is given every three months
Biological: ranibizumab
0.5 mg intravitreal injection
Other Names:
  • Lucentis
Procedure: Sham TTT
Sham Transpupillary thermotherapy (TTT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart
Time Frame: 1 year
1 year
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Kvanta

Investigators

  • Principal Investigator: Anders Kvanta, St Eriks Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (ESTIMATE)

January 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUTA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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